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Pristiq (Desvenlafaxine Succinate) - Summary

 
 



WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PRISTIQ® or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PRISTIQ is not approved for use in pediatric patients [see Warnings and Precautions (5.1), Use in Specific Populations (8.4), and Patient Counseling Information (17.1)].

 

PRISTIQ SUMMARY

PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.

PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [ see Clinical Studies ( 14 ) and Dosage and Administration ( 2.1 ) ]. The efficacy of PRISTIQ has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.


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NEWS HIGHLIGHTS

Media Articles Related to Pristiq (Desvenlafaxine)

Brain Inflammation Tied to Depression, Suicidal Thoughts
Source: Medscape Pathology & Lab Medicine Headlines [2017.09.29]
Animal and postmortem studies point to a link between neuroinflammation and depression and suicidality. This study used PET scans to corroborate these findings in living human beings.
Medscape Medical News

Sleep Deprivation a Rapid, Effective Depression Treatment
Source: Medscape Psychiatry & Mental Health Headlines [2017.09.27]
Sleep deprivation therapy may offer a rapid and effective treatment for depression, but results are short-lived. The question now is how to sustain benefit.
Medscape Medical News

Postpartum Depression Likely to Recur With Future Pregnancies
Source: MedicineNet Depression Specialty [2017.09.27]
Title: Postpartum Depression Likely to Recur With Future Pregnancies
Category: Health News
Created: 9/26/2017 12:00:00 AM
Last Editorial Review: 9/27/2017 12:00:00 AM

Cancer Patients May Have Undiagnosed Depression
Source: MedicineNet Depression Specialty [2017.09.25]
Title: Cancer Patients May Have Undiagnosed Depression
Category: Health News
Created: 9/25/2017 12:00:00 AM
Last Editorial Review: 9/25/2017 12:00:00 AM

Asthma Drug Tied to Nightmares, Depression
Source: MedicineNet Allergy Specialty [2017.09.22]
Title: Asthma Drug Tied to Nightmares, Depression
Category: Health News
Created: 9/21/2017 12:00:00 AM
Last Editorial Review: 9/22/2017 12:00:00 AM

more news >>

Published Studies Related to Pristiq (Desvenlafaxine)

Is desvenlafaxine effective and safe in the treatment of menopausal vasomotor symptoms? A meta-analysis and meta-regression of randomized double-blind controlled studies. [2014]
but its safety margin and tolerability are not yet determined... CONCLUSION: Desvenlafaxine is effective in the treatment of hot flashes but it is

Post hoc analysis of the efficacy and safety of desvenlafaxine 50 mg/day in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. [2014]
study... CONCLUSIONS: Desvenlafaxine 50 mg/day is effective in treating depression in both

Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. [2013]
CONCLUSIONS: Short-term treatment with desvenlafaxine 50 mg/d was effective for

Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. [2013]
population followed for 1 year... CONCLUSIONS: There is no evidence for an increased risk of cardiovascular,

Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. [2013]
moderate to severe hot flashes per week... CONCLUSIONS: Postmenopausal women with moderate to severe hot flashes who are

more studies >>

Clinical Trials Related to Pristiq (Desvenlafaxine)

Retrospective Study Evaluating The Current Utilization Of Desvenlafaxine Succinate Sustained-Release (Pristiq) Among Psychiatrists And Primary Care Physicians In The Treatment Of Patients With Major Depressive Disorder [Completed]
The goal of this observational study is to learn about how Pristiq is currently being used in general practice and how psychiatrists and primary care physicians currently perceive Pristiq in terms of efficacy, tolerability, and adherence compared to other treatments for major depressive disorder (MDD).

Desvenlafaxine in Opioid-Dependent Patients [Recruiting]
Background: Although substitution therapy has been shown to be highly effective to retain opioid-dependent patients in treatment and reduce drug use, this population is afflicted by numerous conditions including depression. Unfortunately, studies published thus far have reported inconsistent or no difference in response between placebo therapy and antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of DESV 50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms at the Centre hospitalier de l'Université de Montréal. Significance: This pilot study will lay down the foundation on which a larger multisite clinical trial could be conducted to examine DESV as new treatment for opioid-dependent population with comorbid depression.

12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder [Completed]

Desvenlafaxine vs. Placebo Treatment of Chronic Depression [Recruiting]
The investigators are studying a new antidepressant medicine, desvenlafaxine, for the treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with a type of chronic depression that is less severe than major depression. This condition is also known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years, often causes significant suffering and impairment. In addition, the investigators are using MRI imaging, which uses magnetic signals to make pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in this study is to see whether chronic depression is associated with differences in brain structure or functioning, and whether such differences change after medication or placebo treatment. To test this MRI scans are done at the start of the study and after 12 weeks of medication or placebo treatment. Getting MRI imaging will be an option for participants in this study but is not required. This study involves a 6 to 12 week double-blind period during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved antidepressant medication. Assessments (of depressive symptoms, social functioning, and personality) will be done by study staff and by patients before the study starts, at each study visit for the first 12 weeks, and again after 24 weeks in the study.

Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women [Recruiting]
The main objective of this study is to characterize a range of brain activation symptoms associated with depression and response to treatment in midlife men and women with MDD, using MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine whether these brain activation symptoms are related to menopausal symptoms (i. e., hot flashes and night sweats). Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

more trials >>

Reports of Suspected Pristiq (Desvenlafaxine) Side Effects

Drug Ineffective (223)Nausea (202)Depression (198)Dizziness (180)Anxiety (168)Feeling Abnormal (158)Malaise (157)Headache (146)Insomnia (128)Withdrawal Syndrome (117)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 11 ratings/reviews, Pristiq has an overall score of 7.27. The effectiveness score is 7.82 and the side effect score is 7.45. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Pristiq review by 52 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Depression
Dosage & duration:   50mg taken once daily for the period of I have been taking this drug for 6 month
Other conditions:   anxiety
Other drugs taken:   xanax
  
Reported Results
Benefits:   This is an NSRI, different from an SSRI because it works on more than one brain chemical. When an SSRI is ineffective or a patient finds that after a period of time a working drug stops working and symptoms of depression return they may be advised to try an NSRI. This was the case with me. I have been treated for my depression for years and had done extremely well for periods of time on several different drugs at different times. Moving from one to the next as I bottomed out on each. Celexa and Lexapro being the most recent. When Lexapro let me down after a couple of years I was advised to try Pristiq which was just released only a few months before my doctor suggested it. I was extremely hesitant as I did not want to go through another adjustment period of sleeplessness, headaches, possible weight gain, sexual issues, etc. You know the drill if you have taken drugs for deperession. So I chose to stay on my Lexapro and be depressed, hoping that it would start working again at a higher dose. Wrong. Getting to the end of my rope with my depression I finally decided to bite the bullet and try the Prestiq. My depression disappeared within 3 weeks leaving me feeling better than I had in months. I began smiling again and fully functioning doing the things I enjoy and had let slide. My sense of well being and hopefulness for the future returned.
Side effects:   Honestly, none for me. I sleep, did not gain an ounce, in fact I lost a small amount of weight even though I did not need to, no sexual side effect at all! Only thing that was tough was waiting for the dosage level to become theraputic in my system, which as I mentioned took about 3 weeks.
Comments:   I was instructed to continue on the Lexapro at a lower dose for one week. At the 2nd week add my dose of Pristiq to the lower dose of Lexapro, at the 3rd week drop the Lexapro completely and continue on my dose of Pristiq. This was done while staying in contact with my prescribing doctor. Now I take 1 50mg tablet everyday of Pristiq, and am doing very well.

 

Pristiq review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   40 mg taken once daily for the period of two years
Other conditions:   ADHD
Other drugs taken:   Vyvanse
  
Reported Results
Benefits:   Pristiq elevated mood and energy levels.
Side effects:   Increased anxiety
Comments:   Pristiq was prescribed at a 20 mg dose and then increased to 40 mg dose. I continue to take it as it has been the most effective medication for alleviating symptoms of depression that I have tried, including Prozac, Effexor, Wellbutrin and Lexapro.

 

Pristiq review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   severe depression
Dosage & duration:   50mg taken 50 mg once daily for the period of little more than 2 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I had no benefits
Side effects:   Nausea, dizziness, increased anxiety, and extreme irritibility.
Comments:   I could not control my irritability. It was out of control. I felt like I was not myself. When starting my third week on this med, I stopped. By day two I felt much better. Would not try this drug again. Had only slight nausea after stopping this medications that quickly went away. My depression worsened on this med. Would not recommend.

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Page last updated: 2017-09-29

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